Positioning risankizumab in the treatment algorithm of moderate-to-severe Crohn's disease

References

• Torres J, Bonovas S, Doherty G et al. ECCO Guidelines on therapeutics in Crohn's disease: medical treatment. J. Crohn's Colit. 2020;14(1):4–22. doi: 10.1093/ecco-jcc/jjz180
   PubMed Web of Science ®Google Scholar
• Chang JT. Pathophysiology of inflammatory bowel diseases. N. Engl. J. Med. 2020;383(27):2652–2664. doi: 10.1056/NEJMra2002697
   PubMed Web of Science ®Google Scholar
• Alatab S, Sepanlou SG, Ikuta K et al. The Global, Regional, and National Burden of Inflammatory Bowel Disease in 195 Countries and Territories, 1990–2017: A Systematic Analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol. Hepatol. 2020;5(1):17–30. doi: 10.1016/S2468-1253(19)30333-4
   PubMed Web of Science ®Google Scholar
• Roda G, Chien Ng S, Kotze PG et al. Crohn's disease. Nat. Rev. Dis. Primers 2020;6(1):22. doi: 10.1038/s41572-020-0156-2
   PubMedGoogle Scholar
• Turner D, Ricciuto A, Lewis A et al. STRIDE-II: an update on the selecting therapeutic targets in inflammatory bowel disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology 2021;160(5):1570–1583. doi: 10.1053/j.gastro.2020.12.031
   PubMed Web of Science ®Google Scholar
• Danese S, Fiorino G, Fernandes C et al. Catching the therapeutic window of opportunity in early Crohn's disease. Curr. Drug Targets 2014;15(11):1056–1063. doi: 10.2174/1389450115666140908125738
   PubMed Web of Science ®Google Scholar
• Van Der Have M, Mangen M-JJ, Van Der Valk ME et al. Effect of aging on healthcare costs of inflammatory bowel disease: a glimpse into the future. Inflamm. Bowel Dis. 2014;20(4):637–645. doi: 10.1097/01.MIB.0000442677.55051.03
   PubMed Web of Science ®Google Scholar
• EMA. https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf ( Accessed Jul, 27, 2023).
   Google Scholar
• Singh S, Murad MH, Fumery M et al. Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis. Lancet Gastroenterol. Hepatol. 2021;6(12):1002–1014. doi: 10.1016/S2468-1253(21)00312-5
   PubMed Web of Science ®Google Scholar
• Grossberg LB, Papamichael K, Cheifetz AS. Review article: emerging drug therapies in inflammatory bowel disease. Aliment. Pharmacol. Ther. 2022;55(7):789–804. doi: 10.1111/apt.16785
   PubMed Web of Science ®Google Scholar
• EMA. https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf ( Accessed Jul, 30, 2023).
   Google Scholar
• Neurath MF, Fuss I, Kelsall BL, Stüber E, Strober W. Antibodies to interleukin 12 abrogate established experimental colitis in mice. J. Exp. Med. 1995;182(5):1281–1290. doi: 10.1084/jem.182.5.1281
   PubMed Web of Science ®Google Scholar
• Teng MWL, Bowman EP, McElwee JJ et al. IL-12 and IL-23 cytokines: from discovery to targeted therapies for immune-mediated inflammatory diseases. Nat. Med. 2015;21(7):719–729. doi: 10.1038/nm.3895
   PubMed Web of Science ®Google Scholar
• Oppmann B, Lesley R, Blom B et al. Novel P19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12. Immunity 2000;13(5):715–725. doi: 10.1016/s1074-7613(00)00070-4
   PubMed Web of Science ®Google Scholar
• Cua DJ, Sherlock J, Chen Y et al. Interleukin-23 rather than interleukin-12 is the critical cytokine for autoimmune inflammation of the brain. Nature 2003;421(6924):744–748. doi: 10.1038/nature01355
   PubMed Web of Science ®Google Scholar
• Tang C, Chen S, Qian H et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology 2012;135(2):112–124. doi: 10.1111/j.1365-2567.2011.03522.x
   PubMed Web of Science ®Google Scholar
• Parigi TL, Iacucci M, Ghosh S. Blockade of IL-23: what is in the pipeline? J. Crohns Colit. 2022;16(Suppl. 2):ii64–ii72. doi: 10.1093/ecco-jcc/jjab185
   PubMed Web of Science ®Google Scholar
• Duerr RH, Taylor KD, Brant SR et al. A genome-wide association study identifies IL23R as an inflammatory bowel disease gene. Science 2006;314(5804):1461–1463. doi: 10.1126/science.1135245
   PubMed Web of Science ®Google Scholar
• Yen D, Cheung J, Scheerens H et al. IL-23 is essential for T cell-mediated colitis and promotes inflammation via IL-17 and IL-6. J. Clin. Invest. 2006;116(5):1310–1316. doi: 10.1172/JCI21404
   PubMed Web of Science ®Google Scholar
• Leppkes M, Becker C, Ivanov II et al. RORgamma-expressing Th17 cells induce murine chronic intestinal inflammation via redundant effects of IL-17A and IL-17F. Gastroenterology 2009;136(1):257–267. doi: 10.1053/j.gastro.2008.10.018
   PubMed Web of Science ®Google Scholar
• Jefremow A, Neurath MF. All are equal, some are more equal: targeting IL-12 and 23 in IBD – a clinical perspective. Immunotarg. Ther. 2020;9:289–297. doi: 10.2147/ITT.S282466
   PubMed Web of Science ®Google Scholar
• Liu M, Zhu W, Wang J et al. Interleukin-23 receptor genetic polymorphisms and ulcerative colitis susceptibility: a meta-analysis. Clin. Res. Hepatol. Gastroenterol. 2015;39(4):516–525. doi: 10.1016/j.clinre.2014.10.009
   PubMed Web of Science ®Google Scholar
• Mathur R, Alam MM, Zhao X-F et al. Induction of autophagy in Cx3cr1+ mononuclear cells limits IL-23/IL-22 axis-mediated intestinal fibrosis. Mucos. Immunol. 2019;12(3):612–623. doi: 10.1038/s41385-019-0146-4
   PubMed Web of Science ®Google Scholar
• Santacroce G, Lenti MV, Di Sabatino A. Therapeutic targeting of intestinal fibrosis in Crohn's disease. Cells 2022;11(3):429. doi: 10.3390/cells11030429
   PubMed Web of Science ®Google Scholar
• Sands BE, Sandborn WJ, Panaccione R et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N. Engl. J. Med. 2019;381(13):1201–1214. doi: 10.1056/NEJMoa1900750
   PubMed Web of Science ®Google Scholar
• Feagan BG, Sandborn WJ, Gasink C et al. Ustekinumab as induction and maintenance therapy for Crohn's disease. N. Engl. J. Med. 2016;375(20):1946–1960. doi: 10.1056/NEJMoa1602773
   PubMed Web of Science ®Google Scholar
• Almradi A, Hanzel J, Sedano R et al. Clinical trials of IL-12/IL-23 inhibitors in inflammatory bowel disease. BioDrugs 2020;34(6):713–721. doi: 10.1007/s40259-020-00451-w
   PubMed Web of Science ®Google Scholar
• Torres T. Selective interleukin-23 P19 inhibition: another game changer in psoriasis? Focus on risankizumab. Drugs 2017;77(14):1493–1503. doi: 10.1007/s40265-017-0794-1
   PubMed Web of Science ®Google Scholar
• Zhou L, Wang Y, Wan Q et al. A non-clinical comparative study of IL-23 antibodies in psoriasis. mAbs 2021;13(1):1964420. doi: 10.1080/19420862.2021.1964420
   PubMed Web of Science ®Google Scholar
• Gordon KB, Strober B, Lebwohl M et al. Efficacy and safety of Risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled Phase III trials. Lancet 2018;392(10148):650–661. doi: 10.1016/S0140-6736(18)31713-6
   PubMed Web of Science ®Google Scholar
• FDA. https://www.accessdata.fda.gov:drugsatfda_docs:label:2022:761262s000lbl.pdf ( Accessed Jul, 30, 2023).
   Google Scholar
• Khatri A, Cheng L, Camez A et al. Lack of effect of 12-week treatment with risankizumab on the pharmacokinetics of cytochrome P450 probe substrates in patients with moderate-to-severe chronic plaque psoriasis. Clin. Pharmacokinet. 2019;58(6):805–814. doi: 10.1007/s40262-018-0730-x
   PubMed Web of Science ®Google Scholar
• Suleiman AA, Goebel A, Bhatnagar S et al. Population pharmacokinetic and exposure-response analyses for efficacy and safety of risankizumab in patients with active Crohn's disease. Clin. Pharmacol. Ther. 2022;113(4):839–850. doi: 10.1002/cpt.2831
   Web of Science ®Google Scholar
• Ferrante M, Panaccione R, Baert F et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal Phase III FORTIFY maintenance trial. Lancet 2022;399(10340):2031–2046. doi: 10.1016/S0140-6736(22)00466-4
   PubMed Web of Science ®Google Scholar
• Feagan BG, Sandborn WJ, D'Haens G et al. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled Phase II study. Lancet 2017;389(10080):1699–1709. doi: 10.1016/S0140-6736(17)30570-6
   PubMed Web of Science ®Google Scholar
• Feagan BG, Panes J, Ferrante M et al. Risankizumab in patients with moderate-to-severe Crohn's disease: an open-label extension study. Lancet Gastroenterol. Hepatol. 2018;3(10):671–680. doi: 10.1016/S2468-1253(18)30233-4
   PubMed Web of Science ®Google Scholar
• Ferrante M, Feagan BG, Panes J et al. Long-term safety and efficacy of risankizumab treatment in patients with Crohn's disease: results from the Phase II open-label extension study. J. Crohns Colit. 2021;15(12):2001–2010. doi: 10.1093/ecco-jcc/jjab093
   PubMed Web of Science ®Google Scholar
• D'Haens G, Panaccione R, Baert F et al. Risankizumab as induction therapy for Crohn's disease: results from the Phase III ADVANCE and MOTIVATE induction trials. Lancet 2022;399(10340):2015–2030. doi: 10.1016/S0140-6736(22)00467-6
   PubMed Web of Science ®Google Scholar
• Abbvie. https://news.abbvie.com/2023-10-15-AbbVies-SKYRIZI-R-risankizumab-Versus-STELARA-R-ustekinumab-Head-to-Head-Study-in-Crohns-Disease-Meets-All-Primary-and-Secondary-Endpoints ( Accessed Oct, 31, 2023).
   Google Scholar
• Fumery M, Defrance A, Roblin X et al. Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: a GETAID multicentre cohort study. Aliment. Pharmacol. Ther. 2023;57(4):426–434. doi: 10.1111/apt.17358
   PubMed Web of Science ®Google Scholar
• Bar-Gil Shitrit A, Gil Y, Israeli E et al. P635 risankizumab – real world Israeli data in severe refractory IBD patients. J. Crohn's Colit. 2023;17(Suppl. 1):i767–i768. doi: 10.1093/ecco-jcc/jjac190.0765
   PubMedGoogle Scholar
• Dawson P, Sharma E, Dart R et al. P19 risankizumab in Crohn's disease: real world experience from a pre-approval access program. In Poster Presentat. BMJ Publish. Group Ltd British Soc. Gastroenterol. 2022;71(Suppl. 1):A45.2–A46. doi: 10.1136/gutjnl-2022-BSG.81
   Google Scholar
• Blauvelt A, Leonardi CL, Gooderham M et al. Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate-to-severe plaque psoriasis: a Phase III randomized clinical trial. JAMA Dermatol. 2020;156(6):649. doi: 10.1001/jamadermatol.2020.0723
   PubMed Web of Science ®Google Scholar
• Warren RB, Blauvelt A, Poulin Y et al. Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a Phase III, randomized, open-label, efficacy-assessor-blinded clinical trial. Br. J. Dermatol. 2021;184(1):50–59. doi: 10.1111/bjd.19341
   PubMed Web of Science ®Google Scholar
• Reich K, Gooderham M, Thaçi D et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled Phase III trial. Lancet 2019;394(10198):576–586. doi: 10.1016/S0140-6736(19)30952-3
   PubMed Web of Science ®Google Scholar
• Papp KA, Lebwohl MG, Puig L et al. Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up. Br. J. Dermatol. 2021;185(6):1135–1145. doi: 10.1111/bjd.20595
   PubMed Web of Science ®Google Scholar
• Gordon KB, Lebwohl M, Papp KA et al. Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis*. Br. J. Dermatol. 2022;186(3):466–475. doi: 10.1111/bjd.20818
   PubMed Web of Science ®Google Scholar
• Brondfield MN, Mahadevan U. Inflammatory bowel disease in pregnancy and breastfeeding. Nat. Rev. Gastroenterol. Hepatol. 2023;20(8):504–523. doi: 10.1038/s41575-023-00758-3
   PubMed Web of Science ®Google Scholar
• Kucharzik T, Ellul P, Greuter T et al. ECCO Guidelines on the prevention, diagnosis, and management of infections in inflammatory bowel disease. J. Crohn's Col. 2021;15(6):879–913. doi: 10.1093/ecco-jcc/jjab052
   PubMed Web of Science ®Google Scholar
• Cote MP, Lubowitz JH, Brand JC, Rossi MJ. Understanding Network Meta-Analysis (NMA) conclusions requires scrutiny of methods and results: introduction to NMA and the geometry of evidence. Arthroscopy 2021;37(7):2013–2016. doi: 10.1016/j.arthro.2021.04.070
   PubMed Web of Science ®Google Scholar
• Hanauer SB, Feagan BG, Lichtenstein GR et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002;359(9317):1541–1549. doi: 10.1016/S0140-6736(02)08512-4
   PubMed Web of Science ®Google Scholar
• Sands BE, Irving PM, Hoops T et al. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, Phase IIIb trial. Lancet 2022;399(10342):2200–2211. doi: 10.1016/S0140-6736(22)00688-2
   PubMed Web of Science ®Google Scholar
• Talathi S, Baig KRKK. Biosimilars in inflammatory bowel disease. J. Dig. Dis. 2020;21(11):610–620. doi: 10.1111/1751-2980.12940
   PubMed Web of Science ®Google Scholar
• Gisondi P, Loconsole F, Raimondo P, Ravasio R. Cost per responder for risankizumab vs secukinumab in patients with moderate-to-severe plaque psoriasis in Italy. Glob. Reg. Health Technol. Assess 2021;8:120–130. doi: 10.33393/grhta.2021.225
   PubMed Web of Science ®Google Scholar
• Bashir NS, Hughes A, Ungar WJ. Infliximab pricing in international economic evaluations in inflammatory bowel disease to inform biologic and biosimilar access policies: a systematic review. MDM Policy Pract. 2023;8(1):23814683231156433. doi: 10.1177/23814683231156433
   Google Scholar
• GaBI Journal Editor. Patent Expiry Dates for Biologicals: 2018 Update. GaBI J. 2019;8(1):24–31. doi: 10.5639/gabij.2019.0801.003
   Google Scholar
• Papp KA, Blauvelt A, Bukhalo M et al. Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N. Engl. J. Med. 2017;376(16):1551–1560. doi: 10.1056/NEJMoa1607017
   PubMed Web of Science ®Google Scholar
• Horst S, Cross RK. Clinical evaluation of risankizumab in the treatment of adults with moderately to severely active Crohn's disease: patient selection and reported outcomes. Drug Des. Devel. Ther. 2023;17:273–282. doi: 10.2147/DDDT.S379446
   PubMed Web of Science ®Google Scholar
• Ferrante M, Peyrin-Biroulet L, Dignass A et al. S715 clinical and endoscopic improvements with risankizumab induction and maintenance dosing versus placebo are observed irrespective of number of prior failed biologics. Am. J. Gastroenterol. 2022;117(Suppl. 10):e498–e499. doi: 10.14309/01.ajg.0000859500.54469.44
   Web of Science ®Google Scholar
• Sandborn WJ, D'Haens GR, Reinisch W et al. Guselkumab for the treatment of Crohn's disease: induction results from the Phase II GALAXI-1 study. Gastroenterology 2022;162(6):1650–1664.e8. doi: 10.1053/j.gastro.2022.01.047
   PubMed Web of Science ®Google Scholar
• Sands BE, Peyrin-Biroulet L, Kierkus J et al. Efficacy and safety of mirikizumab in a randomized Phase II study of patients with Crohn's disease. Gastroenterology 2022;162(2):495–508. doi: 10.1053/j.gastro.2021.10.050
   PubMed Web of Science ®Google Scholar
• Regueiro M, Kip KE, Baidoo L, Swoger JM, Schraut W. Postoperative therapy with infliximab prevents long-term Crohn's disease recurrence. Clin. Gastroenterol. Hepatol. 2014;12(9):1494–1502.e1. doi: 10.1016/j.cgh.2013.12.035
   PubMed Web of Science ®Google Scholar
• Sands BE, Anderson FH, Bernstein CN et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N. Engl. J. Med. 2004;350(9):876–885. doi: 10.1056/NEJMoa030815
   PubMed Web of Science ®Google Scholar
• Colombel J-F, Schwartz DA, Sandborn WJ et al. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut 2009;58(7):940–948. doi: 10.1136/gut.2008.159251
   PubMed Web of Science ®Google Scholar
• Sinagra E, Perricone G, Romano C, Cottone M. Heart failure and anti tumor necrosis factor-alpha in systemic chronic inflammatory diseases. Eur. J. Intern. Med. 2013;24(5):385–392. doi: 10.1016/j.ejim.2012.12.015
   PubMed Web of Science ®Google Scholar
• Battat R, Lukin D, Scherl EJ et al. Immunogenicity of tumor necrosis factor antagonists and effect of dose escalation on anti-drug antibodies and serum drug concentrations in inflammatory bowel disease. Inflamm. Bowel Dis. 2021;27(9):1443–1451. doi: 10.1093/ibd/izaa313
   PubMed Web of Science ®Google Scholar